Johnson & Johnson companies are equal opportunity employers.
Staff Regulatory Compliance Specialist-8421141104
Description
Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Regulatory Compliance Specialist located in Jacksonville, FL.
Johnson & Johnson Vision Care, Inc.,- Vistakon® Division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUE® Brand contact lenses. Our products include ACUVUE® OASYS™ Brand Contact Lenses, 1-DAY ACUVUE® Brand Contact Lenses, and ACUVUE® ADVANCE® Brand Contact Lenses. Ever since ACUVUE® transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. And we're proud that ACUVUE® lenses are worn by more people than any other brand.
The Staff Regulatory Compliance Specialist will plan, coordinate, and conduct quality system audits of JJVC facilities and supportive activities as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements. Facilities include worldwide operations, including the United States, Europe, and Asia. He/she will provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures. The individual will review and monitor required corrective actions; conduct follow-up activities on required action items, as well as assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel. The Staff Regulatory Compliance Specialist will be responsible for providing support for FDA and other governmental or ISO Notified Body inspections conducted at JJVC locations, including readiness activities, front and back room participation/management and general inspection support as requested. He/she will serve as company representative during regulatory inspections, support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary. The individual will consult with management, manufacturing, R&D, marketing company and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls. The Staff Regulatory Compliance Specialist will maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues. He/she will develop and maintains key quality and compliance performance metrics. Participates in developing and presenting departmental materials for Management Review and Annual Product Reviews. The individual will lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to some, if not all, of the following areas: medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions.
The Staff Regulatory Compliance Specialist conducts internal and external QSR / GMP / ISO quality system audits and follow-up activities. He/she assists project teams with identification of quality system requirements to ensure compliance. The individual acts as a liaison with external auditors during third party / regulatory audits. The Specialist monitors regulatory agencies for changes in requirements and evaluates impact to the organization. He/she performs other related duties as assigned by management and promotes a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
Qualifications
A Bachelors degree in a scientific discipline OR a Bachelors degree and a relevant certification (RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor) is required. A minimum of 6 years of working experience in the quality assurance / compliance audit environment required. A minimum of 5 years auditing experience is required. Strong communication, organizational, negotiation and interpersonal skills are required. Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments is required. Experience managing External Regulatory / Notified Body Inspections (e.g. FDA, Anvisa, Florida DoH, BSi, etc) is required.
This position will require the ability to interact with cross functional groups. Demonstrated leadership abilities are required; as well as a demonstrated ability to manage projects / activities.
This position will be located in Jacksonville, FL and may require up to 35% travel.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, apply to this position today!
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)
Job Function: Regulatory Compliance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Staff Regulatory Compliance Specialist-8421141104
Description
Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Regulatory Compliance Specialist located in Jacksonville, FL.
Johnson & Johnson Vision Care, Inc.,- Vistakon® Division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUE® Brand contact lenses. Our products include ACUVUE® OASYS™ Brand Contact Lenses, 1-DAY ACUVUE® Brand Contact Lenses, and ACUVUE® ADVANCE® Brand Contact Lenses. Ever since ACUVUE® transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. And we're proud that ACUVUE® lenses are worn by more people than any other brand.
The Staff Regulatory Compliance Specialist will plan, coordinate, and conduct quality system audits of JJVC facilities and supportive activities as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements. Facilities include worldwide operations, including the United States, Europe, and Asia. He/she will provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures. The individual will review and monitor required corrective actions; conduct follow-up activities on required action items, as well as assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel. The Staff Regulatory Compliance Specialist will be responsible for providing support for FDA and other governmental or ISO Notified Body inspections conducted at JJVC locations, including readiness activities, front and back room participation/management and general inspection support as requested. He/she will serve as company representative during regulatory inspections, support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary. The individual will consult with management, manufacturing, R&D, marketing company and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls. The Staff Regulatory Compliance Specialist will maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues. He/she will develop and maintains key quality and compliance performance metrics. Participates in developing and presenting departmental materials for Management Review and Annual Product Reviews. The individual will lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to some, if not all, of the following areas: medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions.
The Staff Regulatory Compliance Specialist conducts internal and external QSR / GMP / ISO quality system audits and follow-up activities. He/she assists project teams with identification of quality system requirements to ensure compliance. The individual acts as a liaison with external auditors during third party / regulatory audits. The Specialist monitors regulatory agencies for changes in requirements and evaluates impact to the organization. He/she performs other related duties as assigned by management and promotes a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
Qualifications
A Bachelors degree in a scientific discipline OR a Bachelors degree and a relevant certification (RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor) is required. A minimum of 6 years of working experience in the quality assurance / compliance audit environment required. A minimum of 5 years auditing experience is required. Strong communication, organizational, negotiation and interpersonal skills are required. Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments is required. Experience managing External Regulatory / Notified Body Inspections (e.g. FDA, Anvisa, Florida DoH, BSi, etc) is required.
This position will require the ability to interact with cross functional groups. Demonstrated leadership abilities are required; as well as a demonstrated ability to manage projects / activities.
This position will be located in Jacksonville, FL and may require up to 35% travel.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, apply to this position today!
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)
Job Function: Regulatory Compliance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement